WO2025005951A1

WO2025005951A1 - Drug delivery system for an implantable medical device

Info

Publication number: WO2025005951A1
Application number: PCT/US2023/036724
Authority: WO
Inventors: Tony Feng; Hoang Oanh VU
Original assignee: Feng's Inc
Current assignee: Feng's Inc
Priority date: 2023-06-27
Filing date: 2023-11-02
Publication date: 2025-01-02
Anticipated expiration: 2025-12-27
Also published as: CN120112247A; US20250000640A1

Abstract

Multiple example embodiments and methods of use of a drug delivery system for an implantable medical device are disclosed herein. The system provides for simultaneous treatment of two separate medical conditions with two separate therapies-a first treatment provided by the implantable device and a second, pharmacologic therapy provided by a medicament loaded into a product well of a drug delivery module. The clinical provides selects the implantable medical device and the drug delivery module separately, according to the conditions and needs of an individual patient, and mechanically coupled together in the operating or procedure room at the time of the implantation procedure. A module insertion assembly and methods of use are also provided.

Description

DRUG DELIVERY SYSTEM FOR AN IMPLANTABLE MEDICAL DEVICE

CROSS REFERENCE TO RELATED APPLCATIONS

[0001] This application claims the benefit of U.S. provisional application number 63/523,639 entitled “Drug Delivery System and Methods for an Implantable Medical Device,” filed on June 27, 2023, the enclosures of which are incorporated entirely by reference herein.

BACKGROUND

Technical Field

[0002] The disclosures herein relate to a drug delivery system for an implantable medical device. Specifically, the disclosed invention relates to components of a drug-eluting device system configured to couple to an implantable medical device and methods of use for attaching the drug-eluting device to an implantable medical device immediately prior to surgical implantation.

State of the Art

[0003] Drug delivery for the treatment of eye diseases has traditionally been by administering small-molecule therapeutics via eyedrops. More recently, intraocular injections have been employed for “back of the eye” delivery of large-molecule compositions to the vitreous body, supra-choroidal space, and sub-retinal space. These methods deliver a single dose of medication and repeated interval dosing is generally necessary for successful treatment. The need for administering multiple doses at scheduled time intervals, however, requires patient compliance. Missed doses and incomplete courses of therapy yield suboptimal results. Patients forget to take their eyedrops or find putting in eyedrops at a scheduled time is inconvenient and disruptive. Moreover, intraocular injections cannot be performed by the patient and are uncomfortable. Even worse, the experience of having a needle inserted into one’s eye is frightening for almost everyone, can be painful, and carries a risk of serious complications that include bleeding, retinal detachment, and infectious ophthalmitis, among others.

[0004] To improve therapeutic outcomes by reducing patient compliance requirements, intra-ocular drug-eluting implants have been developed in recent years. Such intra-ocular drug-eluting implants, however, act solely to provide a therapeutic medicament. The drug-eluting implants currently known in the art address no other clinical issue and have no other therapeutic purpose separate from providing medication proximate to a target tissue, such as the interior of the eye, for example.

[0005] Cataracts are considered a normal consequence of aging. Additionally, cataracts may be caused by or commonly be associated with other diseases of the eye, such as glaucoma, diabetes, history of previous eye surgery or injury, for example. According to the National Eye Institute, most people either have cataracts or have had cataract surgery by age 80. Cataracts are treated surgically. This involves removing the cataract-clouded lens and inserting an intraocular lens (“IOL”) replacement.

[0006] Many different pharmacologic therapies are commonly prescribed to treat this variety of both primary diseases of the eye and secondary ocular pathology arising from systemic illness, like diabetes, in patients who also require cataract surgery. Because cataract patients commonly have other conditions amendable to treatment with intraocular drugs and because patients requiring intraocular injections or daily eyedrops commonly have cataracts, an IOL having drug-eluting capability is desirable. IOLS used in cataract surgery are not, however, “one size fits all.” As with an external corrective lens, i.e., glasses and contact lenses, the eye surgeon selects an IOL having a refractive index, focal length, and diameter suitable for a given individual patient from the many sizes and varieties of IOLs that are currently available.

[0007] It is not practical to provide the necessary variety of specific IOL types, each type configured to deliver one each of the vast range of different medicaments for treating each different eye disease.

[0008] For at least the foregoing reasons, there is a need for a drug delivery system having an implantable medical device which can be coupled to a separate drug-eluting module creating a practical solution to improve patient compliance for long-term treatment of chronic conditions that overcomes the deficiencies discussed herein above. An example of such a drug delivery system is a replacement IOL having an interchangeable drug-eluting mechanism wherein any number of therapeutic medications can be coupled to the IOL immediately prior to implantation, is needed.

BRIEF SUMMARY

[0009] Disclosed herein are embodiments of a drug-delivery implantable medical device system. Example embodiments of a drug-eluting intraocular implant coupled to a drug delivery module are discussed at length, however this it not meant to be limiting. Other implantable medical devices configured for implantation in non-ocular locations throughout the body that are coupled to a drug delivery module at the time of implantation are contemplated by the following disclosures and alternative examples will be apparent to those of skill in the art of implantable medical devices generally.

[0010] A key feature of the example embodiments disclosed herein is the ability to treat two separate, distinct clinical conditions-a first condition treated with an implantable medical device and a second, distinct, and possibly unrelated condition with a timed- release drug-eluting composition containing a medicament loaded into a product well of a drug delivery module that is coupled to the implantable medical device at the time of the implantation procedure. The capability to delivery a therapeutic medication directly to a target tissue minimizes the amount of medication entering the patient, reduces the overall amount of medication needed, and, in many cases, is more efficacious than oral, topical, topical drops, inhaled aerosols, or other more generalized delivery methods that do not focus a concentrated, continuous, timed-release done of the therapeutic medicament proximate to the tissue target of the therapeutic medication. Two separate conditions can be treated efficiently because the drug delivery module pre-loaded with a therapeutic medicament may be selected separately from the implantable medical device, making possible dozens or even hundreds of possible combinations between different types, sizes, and configurations of the implantable medical device specific to the physical and therapeutic needs of an individual patient and the drug delivery module bearing the pharmacologic therapy selected by the patient’s healthcare providers to treat the second condition.

[0011] Disclosed is a drug delivery system for an implantable medical device comprising an implantable medical device selected to deliver a first treatment for a first condition to an individual patient; and a drug delivery module comprising a medicament selected to deliver a second treatment for a second condition to the individual patient, wherein the drug delivery module becomes coupled to the implantable medical device immediately prior to implantation in the patient.

[0012] In some embodiments, the implantable medical device comprises an intraocular lens. In some embodiments, the medicament is combined with a carrier composition. In some embodiments, the carrier composition is a biopolymer.

[0013] In some embodiments, the first condition is an ocular condition. In some embodiments, the first condition is a cataract. In some embodiments, the second condition is a different condition than the first condition. In some embodiments, the second condition is an ocular condition. In some embodiments, the second condition is glaucoma.

[0014] In some embodiments, the implantable medical device comprises an intraocular lens and a haptic arm coupled to the intraocular lens at a flexible joint; a first coupling feature disposed on the implantable medical device proximate to the flexible joint; and a second coupling feature disposed on the drug delivery module configured to mate with the first coupling feature, wherein coupling of the drug delivery module to the implantable medical device is established and maintained by an interaction between the first coupling feature and the second coupling feature.

[0015] In some embodiments, the drug delivery module comprises a rotation lock. In some embodiments, coupling of the drug delivery module to the implantable medical device is reversible. In some embodiments, coupling of the drug delivery module to the implantable medical device is irreversible.

[0016] Disclosed is a drug delivery system comprising an implantable medical device selected to deliver a first treatment for a first condition of an individual patient; a drug delivery module having at least one sidewall defining a product well; and a module insertion assembly having a top body bearing a first alignment feature, a middle body with a module recess configured to receive the drug delivery module and bearing a second alignment feature, and a base body with an implant recess configured to receive the implantable medical device and bearing a third alignment feature, wherein the middle body is configured to reversibly couple between the base body and the top body by a coaxial interaction between the first alignment feature, the second alignment feature, and the third alignment feature, and wherein compressing the middle body loaded with a drug delivery module in the module recess between the base body loaded with the implantable medical device loaded in the implant recess and the top body by a force applied to the top body under a condition wherein the first alignment feature, the second alignment feature, and the third alignment feature are coaxial causes the drug delivery module to couple to the implantable medical device.

[0017] In some embodiments, the implantable medical device is an intraocular implant. In some embodiments, the module insertion assembly is disposable.

[0018] Disclosed is a kit comprising an implantable medical device; and a module insertion assembly configured to receive the implantable medical device, wherein the module insertion assembly comprises a top body, a middle body, and a base body, and wherein the module insertion assembly is configured to couple a drug delivery module to the implantable medical device.

[0019] In some embodiments, the implantable medical device is an intraocular medical device. In some embodiments, the intraocular medical device comprises an intraocular lens. In some embodiments, he module insertion assembly is disposable.

[0020] The features and advantages of the invention will be apparent to those of ordinary skill in the art from the following more particular and detailed descriptions of selected example embodiments of the disclosed system and methods, along with the accompanying drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 is a top view of a drug-eluting intraocular implant system;

[0022] FIG. 2 is a side view of a drug-eluting intraocular implant system;

[0023] FIG. 3 is a perspective view of a drug-eluting intraocular implant system;

[0024] FIG. 4 is an enlarged perspective view of a drug delivery module of a drugeluting intraocular implant system; [0025] FTG. 5 is an enlarged bottom view of a drug delivery module of a drug-eluting intraocular implant system;

[0026] FIG. 6 is a top view of a drug delivery module of a drug-eluting intraocular implant system;

[0027] FIG. 7 is a side view of a drug delivery module of a drug-eluting intraocular implant system;

[0028] FIG. 8 is an enlarged perspective view of a drug delivery module of a drugeluting intraocular implant system;

[0029] FIG. 9 is an end view of a drug delivery module of a drug-eluting intraocular implant system;

[0030] FIG. 10 is a side view of a drug delivery module of a drug-eluting intraocular implant system;

[0031] FIG. 11 is a second end view diagram of a drug delivery system assembly device;

[0032] FIG. 12 is a cutaway view of a drug delivery module of a drug-eluting intraocular implant system;

[0033] FIG. 13 is a magnified side view of a haptic arm of a drug-eluting intraocular implant system;

[0034] FIG. 14 is an exploded perspective view of a module insertion assembly of a drug-eluting intraocular implant system;

[0035] FIG. 15 is an exploded side view of a module insertion assembly of a drugeluting intraocular implant system; and

[0036] FIG. 16 is a diagram of a method of use of a drug-eluting intraocular implant system.

DETAILED DESCRIPTION

[0037] Various example embodiments of a drug-eluting implantable medical device systems are discussed herein. The system includes an intraocular replacement lens (“IOL”) fitted with a feature to connect with a drug delivery module. The IOL prosthetic and the drug delivery module are selected separately for the individual patient depending on the (1) IOL needed; and (2) planned drug therapy. For example, a variety of IOL replacements are available. Examples of differences between IOLS include diameter, the focal length of the lens, whether the lens is monofocal or toric, and others. An IOL is selected by the eye surgeon in consultation with the patient to provide the optimal IOL design and desired specifications.

[0038] Similarly, there is a wide and growing range of medicaments used to treat eye disease. Accordingly, a drug delivery module may be created having a specific medicament, concentration, and elution mechanism to provide timed intraocular release of the medication. Manufacture of the drug delivery module to deliver a specific medicament selected from any number of pharmaceutical compounds can be coupled with an IOL specific to the patient’s prescription selected separately from the medicament.

[0039] Embodiments of the intraocular drug delivery system incorporate a secure coupling mechanism between the IOL and the drug delivery module whereby the surgeon or other practitioner may easily, quickly, and reliably couple the delivery module to the IOL. Such a simple and reliable mechanism for coupling a drug-eluting attachment to an implantable medical device is particularly important for intraocular implants which are relatively small compared to a surgeon’s hands and where detachment within the eye is potentially more serious and difficult to correct then separation of a drug-eluting attachment from a medical device implanted in other locations.

[0040] In some embodiments, the drug-eluting attachment is configured to couple to a replacement intraocular lens (“IOL”) such as commonly used during cataract surgery. Cataract surgery is an extremely common procedure worldwide, with the 2021 annual worldwide case rate estimated at 20 million. Many patients receiving an IOL during cataract removal have coexisting ocular morbidity, including glaucoma, age-related maculopathy, and diabetic retinopathy. Additionally, postoperative medications to prevent infection, uveitis, posterior capsular opacification, and other sequelae of IOL replacement during cataract surgery are also used. It can be appreciated that many ocular conditions could be treated with a drug-eluting attachment for an IOL replacement device.

Definitions:

[0041] As used herein, “implantable medical device” means any therapeutic medical device designed for implantation within a target tissue of a patient. As used herein, “intraocular implant” means any therapeutic medical device designed for implantation within a tissue comprised by the eye of a patient.

[0042] As used herein, “’’implantation” means surgical implantation, i.e., making an incision through tissue and passing the implantable medical device, such as an intraocular implant, through the incision into a target tissue, such as an eye tissue, and then closing the incision with suture or other suitable means. Implantation includes traditional “open” surgery, minimally invasive surgery, laparoscopic surgery, endoscopic or endo-luminal surgery and other surgical approaches known in the art for placing an implantable medical device into a target tissue of a patient, without limitation.

[0043] As used herein, “immediately prior to implantation” means within a period of time shortly before surgical implantation of an implantable medical device. “Immediately prior” does not have a specific time value but refers to the period of time during a surgical procedure, i.e., in the operating room, procedure room, or patient room where the surgical procedure is taking place rather than in a remote location separate from the operating room or a time separate from the surgical procedure, such as preceding the procedure by hours, days, or longer.

[0044] As used herein, “treatment” means medical care given to a patient for an illness or an injury. Examples of treatment include procedures such as surgery, administration of a medication, and the like.

[0045] As used herein, “ocular” means pertaining to or relating to the eye.

[0046] As used herein, “medicament” means an any composition, compound, drug, or other substance used for medical treatment of a disease or condition. The medicament may include an active medication and a carrier substance or composition, such as a buffer, a thickener, a composition configured dissolve within the target tissue to release the active medication from the composition over an extended period of time (“timed- release”), or the like.

[0047] As used herein, “drug eluting” means releasing a drug from a carrier composition or material over time through the action of a solvent, such as water, interstitial tissue fluid, blood, or any other fluid within the body.

[0048] As used herein, “distal” refers to a direction away from a more central part. Further, any directional references as used herein, such as right, left, up, down, top, bottom, and the like are intended for convenience of description and do not limit the disclosed structures to any particular positional or spatial orientation.

[0049] As used herein, “anterior” means towards the front of an anatomic structure, such as the front of the face, the front of the eye, or the front-side of the body, for example.

[0050] As used herein, “posterior” means towards the back of an anatomic structure, such as the back of the head, the back of the eye, or the back side of the body, for example. Posterior refers to a side, an aspect, or a direction away from or opposite to anterior. Similarly, anterior refers to a side, an aspect, or a direction away from or opposite to posterior. Anterior and posterior relate to an anatomic structure’s position or location.

[0051] As used herein, “radial” or “transverse” refers to a direction orthogonal to a central longitudinal axis of a structure.

[0052] As used herein, “circumferential” or “circumferentially” refers to a curved path around the body of a structure or sub-structure in a plane orthogonal to a central longitudinal axis.

[0053] As used herein, “additional embodiment,” “another additional embodiment,” “yet another additional embodiment,” “separate additional embodiment,” and similar terms refer to different examples of embodiments of drug delivery systems and methods within the scope of the disclosures and teachings found herein, and the components thereof.

[0054] As used herein, “line-of-sighf ’ or “axis of sight” means coaxial with a line passing from anterior to posterior through the center of the pupil, center of the lens, and onto the retina of the eye.

[0055] Details of a drug eluting attachment for an implantable medical device will now be discussed with reference to the several drawing figures. Although many of the embodiments are described herein for implantation within the eye, it is conceived that the concept of providing a similar drug-eluting drug delivery module which may be selected separately from an implantable medical device and coupled to the medical device in the operating room immediately prior to implantation using a simple and reliable coupling feature is within the scope of these disclosures. The utility of such a system as disclosed herein, not merely with an IOL implant but across other implantable medical devices, will be immediately appreciated by one of skill in the art. Implantable Medical Device with Drug Delivery Module

[0056] FIG. 1 is a top view of a drug-eluting intraocular implant system. FIG. 1 shows an example drug delivery system 100 with an implantable medical device 101. In this example, implantable medical device 101 is configured as a replacement intraocular lens (“IOL”)-associated device typically used in cataract surgery. Device 101 comprises an intraocular lens (IOL) 102 and a pair of haptic arms 103. In the example implantable medical device 101 configured for IOL replacement surgery, haptic arms 103 interact with intraocular tissues to retain and center-with respect to the line-of-sight-system 100 in position within the eye. In some embodiments, device 101 is positioned centered beneath the pupil in the posterior chamber, however this is not meant to be limiting. Anterior chamber placement and devices design for scleral fixation may also be used. Haptic arms 103 present a friction grid 105 on a distal segment of each arm 103 to aid in securing system 100 to surrounding ocular tissue, depending upon the type of IOL used and position of placement within the eye. Haptic arms 103 are each coupled to lens 102 at a flexible joint 107. Joint 107 allows haptic arms 103 to be placed under slight compressive tension, such as compressing a spring, to create a resilient connection such that lens 102 remains centered beneath the pupil or otherwise with respect to the cornea and the retina of the eye.

[0057] FIG. 1 additionally shows a first coupling feature 104 disposed on an external surface of device 101 at the location of each flexible joint 107. In some embodiments, the external surface is a top surface, as shown in FIG. 1. In some embodiments, the external surface is a bottom surface or a side surface. First coupling feature 104 is configured to couple, i.e., “mate,” with a corresponding second coupling feature 113 (shown in FIGs. 4-5 and FIGs. 7-12 and FIG. 15) of a drug delivery module 110, discussed at length herein below. In some embodiments, first coupling feature 104 is a bore (hole) through the full thickness of flexible joint 107. This is not meant to be limiting, however. In some embodiments, first coupling feature 104 is a partial thickness bore, may be normal to an external surface of joint 107, or may be angled with respect to the external surface of joint 107. Alternatively, feature 104 may be a projection or other feature protruding and extending a distance from the external surface of joint 107. The specific shape and configuration of feature 104, in any particular embodiment, must match a corresponding complementary feature on the drug delivery module, as will be discussed.

[0058] FIG. 2 is a side view of a drug-eluting intraocular implant system. FIG. 2 shows a drug delivery module 110 coupled to each of two haptic arms 103 proximate to flexible joint 107. As shown in FIG. 2, delivery module 110 is positioned atop the junction between IOL 102 and haptic arm 103. The position of delivery module 110 is shown in greater detail by FIG. 3 below.

[0059] FIG. 3 is a perspective view of a drug-eluting intraocular implant system. FIG. 3 shows drug delivery module 110 coupled to each haptic arm 103 at each flexible joint 107. Note that delivery module 110 is shaped so as not to overlay any light-transmitting portion of lens 102. This is important to prevent module 110 from interfering with vision. This design, shape, and overall configuration of system 100 described herein is specific to medical device 101 configured as an implantable IOL. Alternate shapes and configurations would be used in embodiment of system 100 utilizing other alternative implantable medical devices 101.

[0060] Drug delivery module 110 comprises a product well 112. Product well 112 is configured to retain a medicament for delivery into tissues surrounding the site of implantation of medical device 101. In some embodiments, product well 112 is open, such as the example embodiment shown in FIG. 3 and throughout the several drawing figures. In some embodiments, product well 112 is fenestrated. In some embodiments, product well 112 comprises a permeable membrane constraining the medicament such that the medicament diffuses through the permeable membrane at a predetermined rate consistent with the chemical composition of the medicament and conditions at the implantation anatomic site, such as pH or osmolality, for example. In some embodiments, the medicament is distributed throughout a carrier. In some embodiments, the carrier is a biopolymer. Examples of biopolymers and related drug delivery systems include hydrogels, cellulose-based compositions, other protein-based compositions, and the like are provided by “Recent developments in natural biopolymer-based drug delivery systems” by Fazel, T., et al., Royal Society of Chemistry Advances vol. 13 pp. 23087- 121 (2023), which is incorporated in its entirety herein by reference. Various other controlled or time-release mechanisms for the medicament packaged within product well 112 are contemplated and within the scope of these disclosures.

[0061] Although many different configurations of implantable medical device 101 and drug delivery module 110 are possible, a key element of drug delivery system 100 is to allow a practitioner to select a particular configuration of medical device 101 separately from a medicament and match device 101 with drug delivery module 110 bearing a specific drug delivery composition containing a specific medicament. Medical device 101 is selected according to the implantation site, size of the patient, and other anatomic or physical characteristics specific to the patient independent of the disease condition being treated. Drug delivery module 110 is selected according to the disease condition being treated and is not dependent on physical characteristics of an individual patient. The desired medicament is packaged in a drug delivery composition contained within product well 112. Moreover, medical device 101 and drug delivery module 110 are packaged separately. They may have separate expiration dates, Device 101 and module 110 may be manufactured separately by different manufacturers at different times in separate locations, if needed. The features additionally allow the surgeon or other practitioner to select and couple medical device 101 and drug delivery module 110 immediately prior to implantation, such as in the operating room, for example. In some cases, the surgeon may not be certain of the size or specific model of implantable medical device 101 to be implanted until the implantation site is surgically exposed and examined by the surgeon in the operating room. Consequently, the features listed herein add tremendous versatility to device and drug manufacturing processes, facility inventory, procedure planning, and other treatment aspects specific to an individual patient, along with other advantages.

[0062] FIG. 4 is an enlarged perspective view of a drug delivery module of a drugeluting intraocular implant system. FIG. 4 shows drug delivery module 110 having a body 111 defining product well 112. Second coupling feature 113 is shown projecting from a surface of body 111 opposite product well 111 in this and some other embodiments.

[0063] FIG. 5 is an enlarged bottom view of a drug delivery module of a drug-eluting intraocular implant system FIG. 5 shows second coupling feature 113 generally centered on a bottom surface of body 111. Second coupling feature 113 of drug delivery module 110 is configured to interact with first coupling feature 104 of implantable medical device 101, coupling module 110 to device 101. In the example shown in the several drawing figures and some embodiments, second coupling feature 113 is a mushroomshape projecting “button” such that second coupling feature 113 may be pushed through a corresponding aperture comprised by first coupling feature 104, locking drug delivery module 110 to implantable medical device 111. In some embodiments of system 100 employing this configuration of first coupling feature 104 and second coupling feature 113 feature 113 is partially or completely shaped from a deformable elastic material such that the mushroom-shaped projection may be sufficiently deformed to push through the bore forming first coupling feature 104. In some embodiments, mating of first coupling feature 104 and second coupling feature 113 is reversible. This is desirable and useful for embodiments of system 100 wherein drug delivery module 110 must be replaced one or more times following implantation of medical device 101 when a therapeutic medicament residing in product well 112 becomes depleted and must be replaced. In some embodiments, mating of first coupling feature 104 and second coupling feature 113 is irreversible such that drug delivery module 110 and implantable medical device 101 are permanently inseparable after coupling together. This is desirable and useful for embodiments of system 100 wherein replacement of delivery module 110 is associated with an unacceptably high risk or complications or is otherwise impractical because of the anatomic location wherein implantable medical device 101 is positioned.

[0064] The “button-in-hole” interaction between second coupling feature 113 and first coupling feature 104 shown in the several drawing figures is provided by example only. Other coupling mechanisms are possible, in some embodiments. Some non-limiting example alternative designs of other coupling mechanisms include interacting tabs, clips, snaps, and the like presented by first coupling feature 104 and second coupling feature 113.

[0065] FIGs. 4-5 also shows an example embodiment of body 111 comprising a fixation shelf 114. In some embodiments, fixation shelf 114 resists rotation of delivery module 110 on implantable device 101. Shelf 114, in some embodiments, interacts with a corresponding feature, such as a lip, a rim, or a complementary shelf (not shown in the drawing figures) presented by implantable device 101. A person of skill will see the importance, in some embodiments of system 100 wherein delivery module 1 10 is not rotationally symmetrical, to prevent rotation of module 110 about an axis 120 defined by first and second coupling features from causing undesired interference with physiologic functions at the implantation site. For example, such rotational stability is particularly important when implantable medical device 101 is an IOL device because with any rotation of a crescent-shaped delivery module 110 over lens 102, module 110 will cross into the line-of-sight and enter a light path, interfering with the recipient patent’s vision.

[0066] FIG. 6 is a top view of a drug delivery module of a drug-eluting intraocular implant system. FIG. 7 is a side-view of a drug delivery module of a drug-eluting intraocular implant system. FIG. 8 is an enlarged perspective view of a drug delivery module of a drug-eluting intraocular implant system. FIG 9 is an end view of a drug delivery module of a drug-eluting intraocular implant system. FIGs. 6-9 show several views depicting features of drug delivery module 110, including second coupling feature 113, fixation shelf 114, and product well 112. The embodiment of drug delivery module 110 shown in the drawing figures is specific to drug delivery system 100 incorporating an IOL implantable medical device 101, however other configurations of delivery module 110 are contemplated configured to couple to other implantable medical devices 101 within system 100.

[0067] FIG. 10 is a side view of a drug delivery module for an intraocular drug-eluting intraocular implant system. FIG. 10 shows drug delivery module 110 having body 111 with two rotation locks 114 and second coupling feature 113. As shown in FIG. 10, second coupling feature 113 projects from module 110. In some embodiments, including the example shown in FIG. 10, second coupling feature comprises a head 113a and a projection 113b. Head 113a has a generally frustoconical shape and formed from a resilient material to pass through first coupling feature 104, locking implantable medical device 101 to drug delivery module 110, in some embodiments. In some embodiments, head 113a is formed from a substantially rigid material and first coupling feature 104 is formed from or lined by a layer of substantially deformable, resilient materials to allow passage of head 113a through first coupling feature 104. Projection 113b acts offset head 113a from body 111 to allow full transit of head 113a through first coupling feature 104, in some embodiment. Other configurations of first coupling feature 104 and second coupling feature 1 13, and the form of interaction between first feature 104 and second feature 113 are contemplated by the disclosures herein. FIG. 10 also shows axis of rotation 120 passing through a central long axis of second coupling feature 113.

[0068] FIG. 11 is a second end view diagram of a drug delivery system assembly device and FIG. 12 is a cutaway view of a drug delivery module of a drug-eluting intraocular implant system. FIGs. 11—12 show additional details of some embodiments of drug delivery module 110. In some embodiments, product well 112 and second coupling feature 113 are formed as a unitary body with body 111. In some embodiments, second coupling feature 113 is formed separately from body 111 and later bonded to body 111 by use of adhesives, heat-welding, or other suitable techniques.

[0069] FIG. 13 is a magnified view of the junction of a haptic arm with an intraocular lens of a drug-eluting intraocular implant system. FIG. 13 shows an example of an implantable medical device consistent with system 100 comprising an IOL. Haptic arm 103 is coupled to body 111 at a flexible joint 107. As discussed herein, flexible joint 107 facilitates fixation and centering of implantable medical device 101 configured as an intraocular implant within the eye. Also shown in FIG. 13 is a corresponding feature 115. In embodiments of system 100 wherein drug delivery module 110 is not rotationally symmetrical or otherwise must not rotate with respect to implantable medical device 101, corresponding feature 115 interacts with fixation shelf 114 of drug delivery module 110 to resist rotation of drug delivery module 110 about axis 120 passing through first coupling feature 104 and second coupling feature 113.

Module Insertion Assembly

[0070] Drug-eluting intraocular implant system 100 includes, in some embodiments, a module insertion assembly configured to enable or assist with coupling of implantable medical device 101 and drug delivery module 110. Use of a module insertion assembly is desirable, in some embodiments of system 100, such as for use with an implantable medical device configured for use with a drug delivery module measuring less than about 10 millimeters in greatest dimension. Drug delivery modules of this size and smaller can be difficult to manipulate with the fingers leading to lengthy time spent coupling the drug delivery module to the implantable device. Saving time in the operating room is of paramount importance, for many reasons known to those of skill in the art of surgically implanted medical devices. Coupling an implantable medical device with a drug delivery module requires a controlled application of force to approximate a first coupling feature and a second coupling feature along a properly aligned axis. Improper alignment between the first and second coupling features increased the risk of breakage of delicate components, such as those forming an implantable drug-eluting intraocular device. Also, manipulating small objects increases the risk of dropping device components on the operating room floor resulting in the need to discard a contaminated or damaged drug delivery module or the implantable medical device.

[0071] Consequently, disclosure of the module insertion assembly is provided, at least to (1) reduce operating room time needed for assembly of a drug delivery system; (2) reducing the risk of damaging system components during assembly; and (3) minimizing the risk of ruining potentially expensive components of limited availability through contamination or breakage.

[0072] FIG. 14 an exploded perspective view diagram of a module insertion assembly for a drug delivery system. FIG. 15 is an exploded side view of a module insertion assembly of a drug-eluting intraocular implant system. FIGs. 14-15 show a module insertion assembly 200 of drug-eluting intraocular implant system 100. Module insertion assembly 200, in some embodiments, is formed by aligned, stacked components comprising a base body 206, a middle body 203, and a top body 201. Base body 206, middle body 203 and top body 201 fit together in alignment and are reversibly assembled and disassembled through coaxial alignment of one more series of complementary alignment features, as shown in FIGs. 14-15. In some embodiments, a first alignment feature 202 is disposed on top body 201, a second alignment feature 204 is disposed on middle body 203, and a third alignment feature 208 is disposed on base body 206. In some embodiments, one of either first alignment feature 202 or third alignment feature 208 is formed as a protrusion configured to reversibly couple with a corresponding feature, such as an aperture sized to accommodate the protrusion, forming the other of either first alignment feature 202 or third alignment feature 208.

[0073] Base body 206 includes an implantable medical device receiver 210. Medical device receiver 210 is, essentially, a “cutout” sized and shaped large enough to easily receive the implantable medical device, such as device 101, but not so large as to allow movement of a first coupling feature born by medical device with a second coupling feature displayed by a drug delivery module, such as delivery module 110. In some embodiments used with an IOL implantable device and as shown in FIG. 10, device receiver 210 is dimensioned to receive and constrain an IOL coupled to haptic arms. This is not meant to be limiting. Medical device received can be dimensioned to receive and constrain other implantable medical devices for coupling to drug delivery modules to form system 100, in some other embodiments, without limitation.

[0074] Middle body 203, in some embodiments, comprises one or more module recesses

205. Middle body 203 comprises a first surface 214 and a second surface 216 opposite first surface 214. When top body 201, middle body 203, and base body 206 are assembled, first surface 214 faces top body 201 and second surface 216 faces base body

206. Middle body 203 additionally comprises second alignment feature 204. In some embodiments, including the example shown in FIGs. 14-15, middle alignment feature 204 is an aperture configured to receive a protrusion forming either first alignment feature 202 or third alignment feature 208. Alignment features 202, 204, and 208 function to align corresponding sections of top body 201, middle body 203, and base body 206 so as to maintain first coupling feature 103 of implantable medical device 101 and second coupling feature 113 of drug delivery module 110 aligned along axis 120.

[0075] FIG. 14 also shows a pair of module recesses 205 on middle body 203. Module recess 205 is configured to receive and constrain drug delivery module 210 for coupling with implantable medical device 101, as will be discussed shortly. Middle body 203 is configured to be sandwiched between base body 206 and top body 201, as shown in FIGs. 14-15

[0076] Top body 201 comprises one or more implant presses 209. Each implant press 209 is formed as a protrusion having a profile similar to that presented by drug delivery module 210, as shown in FIG. 15 and in some embodiments. When module insertion assembly 200 is fitted with an implantable medical device and a drug delivery module, and fully assembled or “stacked” and squeezed together, each implant press 209 transmits a force F applied by the user to the loaded and fully assembled module insertion assembly upon each corresponding drug delivery module 110, urging together each corresponding first coupling feature 104 and second coupling feature 113. [0077] FTG. 15 shows middle body 203 atop base body 206. Middle body 203 and base body 206 are seen in FIG. 15 to be substantially aligned by the interaction of a corresponding plurality of alignment features 202, 204, and 208. FIG. 11 also shows a pair of implant presses 209 disposed on an under-surface of top body 201. Each implant press 209 is formed as a protruding feature of the shape and slightly smaller size as a cross-section of drug delivery module 110. Implantable device 101 is received in a recess within base body 206 forming a device receiver 207. Each module recess 205 of middle body 203, as shown in the partially assembled assembly device 100 of FIG. 11, is positioned such that recess 205 overlays coupling feature 104 of implantable device 101 wherein device 101 rests within device receiver 207. In this manner, delivery module 110 can be placed within module recess 205 such that second coupling feature 113 contacts first coupling feature 104. top body 201 is then positioned atop the assembly and aligned by the interaction of first alignment feature 202 and locking alignment feature 208 with push locks 209 contacting a corresponding plurality of drug delivery modules 110. With all sections of assembly device 200 held in alignment and loaded with device 101 and module 110, a force “F” (shown in FIG. 15) is applied to push top body 201 and base body 206 toward one another against middle body 203, thereby forcing first coupling feature 104 and second coupling feature 113 to lock together and “mate” while constraining drug delivery module 110 and implantable medical device device 101 in alignment. In some embodiments, including the example embodiment shown in FIGs. 14-15, this maneuver locks a drug delivery module 110 onto the haptic arm-body juncture of an implantable intraocular medical device 101 proximate to the flexible joint at the mated first and second coupling features 104 and 113 respectively.

[0078] FIG. 14 shows that third alignment feature 208 is configured as a protrusion in some embodiment and a recess in some embodiments. In some embodiments, including the example embodiment shown in FIG. 14, base body 206 comprises a plurality of third alignment features 208, one or more features 208 formed as a protrusion and one or more features 208 formed as a recess. Similarly, top body 201, in some embodiments, comprises a corresponding number of one or more first alignment features 202 to the number of thirst alignment features 208 with a corresponding configuration wherein a recessed feature 202 receives a protrusion feature 208 and a recess feature 208 receives a protrusion feature 202. It is conceived and within the scope of these disclosures that second alignment feature(s) 204 presented by middle body 203 are formed, in some embodiments (not shown in the several drawing figures) as protrusions extending from first surface 214 of middle body 203 and/or second surface 216 of middle body 203 and are received by corresponding recesses forming first alignment feature 202 and third alignment feature 208 respectively.

[0079] FIG. 16 is a diagram of a method of assembling a drug delivery system. FIG 16 shows a method 300 of forming a drug-delivery system for an implantable medical device comprising a positioning step 210, a first placing step 320, a second placing step 330, a third placing step 340, a coupling step 350, and an uncoupling step 360.

[0080] In some embodiments, positioning step 310 comprises positioning an implantable medical device within a base body device receiver. In some embodiments, the implantable medical device is an IOL. In some embodiments, the IOL has haptic arms.

[0081] In some embodiments, first placing step 320 comprises placing a middle body on the base body. In some embodiments, first placing step 320 includes threading one or more second alignment features of the middle body onto a corresponding one or more locking alignment features of the base body such that the middle body is very closely aligned in position atop of the base body. “Aligned in position” means that when the middle body is coupled to the base body, one or more module recesses of the middle body are maintained in position directly above a corresponding positions of the base body device receiver by an interaction between the second alignment feature(s) and third alignment feature(s) such that each first coupling feature of the implantable medical device is aligned over each corresponding second coupling feature of a drug delivery module loaded into each module recess of the middle body.

[0082] In some embodiments, second placing step 330 comprises placing one or more drug delivery modules within a corresponding number of module recesses within the middle body after the middle body has been positioned atop and aligned with the base body. The drug delivery modules are placed such that a second coupling feature of the drug delivery module resting within the module recess contacts a corresponding first coupling feature of the implantable medical device constrained within the device receiver of the base body and held in place by the middle body. [0083] In some embodiments, third placing step 340 comprises placing a top body on the middle and base body. Third placing step 240 includes positioning a first alignment feature of the top body onto the locking alignment feature of the base body such that the top body is very closely aligned atop the middle body wherein one or more push locks are positioned in contact with the corresponding number of drug delivery modules.

[0084] In some embodiments, coupling step 350 comprises coupling the top, middle and base bodies. In some embodiments, this is accomplished simply by pushing the top body and the base body together; i.e., by applying a downward force to the top body or by compressing together the top, middle, and base bodies, such that the one or more drug delivery modules loaded into the middle body are snap-locked onto the implantable medical device loaded into the base body by a mating of the corresponding first and second coupling features of the implantable medical device and the drug delivery module(s).

[0085] In some embodiments, uncoupling step 260 comprises uncoupling the top body and the middle body from the base body and removing the assembled drug delivery system.

[0086] In some embodiments, module insertion assembly 200 is packaged together with one or more drug delivery modules as part of a kit. In some embodiments, the module insertion assembly is provided pre-packaged in sterile packaging. In some embodiments, module insertion assembly 200 is clean-packaged and later sterilized by the end-user. In some embodiments, module insertion assembly 200 is disposable. In some embodiments, module insertion assembly 200 is re-usable.

[0087] Several embodiments of a drug delivery system for an implantable medical device have been presented. The drug delivery system creates versatility by choosing a drug delivery module containing a specific medicament for coupling with a specific size and configuration of an implantable medical device for use in locations wherein many device sizes and configurations are needed and many therapeutic medicinal compositions may be used to increase therapeutic efficacy by eliminating patient self-dosing and associated problems with compliance. This is particularly useful in the eye, where a drug delivery module may be selected and easily, securely coupled to an IOL in the operating room immediately prior to implantation. Other combinations of implantable medical devices fited with a coupling feature for securely coupling to a drug delivery module are contemplated by such a system. In some embodiments, the drug delivery system for an implantable medical device includes a module insertion assembly to decrease operating room time, reduce breakage and contamination, and facilitate assembly and use of the implantable medical device coupled to a drug delivery module.

[0088] The embodiments and examples set forth herein were presented in order to best explain the present invention and its practical application, and to thereby enable those of ordinary skill in the art to make and use the invention. However, those of ordinary skill in the art will recognize that the foregoing description and examples have been presented for the purpose of illustration and example. The description as set forth is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible, in light of the teachings herein above.

Claims

CLAIMS What is claimed is:

1. A drug delivery system for an implantable medical device comprising: an implantable medical device selected to deliver a first treatment for a first condition to an individual patient; and a drug delivery module comprising a medicament selected to deliver a second treatment for a second condition to the individual patient, wherein the drug delivery module becomes coupled to the implantable medical device immediately prior to implantation in the patient.

2. The drug delivery system of claim 1, wherein the implantable medical device comprises an intraocular lens.

3. The drug delivery system of claim 1, wherein the medicament is combined with a carrier composition.

4. The drug delivery system of claim 3, wherein the carrier composition is a biopolymer.

5. The drug delivery system of claim 1, wherein the first condition is an ocular condition.

6. The drug delivery system of claim 3, wherein the first condition is a cataract.

7. The drug delivery system of claim 1, wherein the second condition is a different condition than the first condition.

8. The drug delivery system of claim 5, wherein the second condition is an ocular condition.

9. The drug delivery system of claim 6, wherein the second condition is glaucoma.

10. The drug delivery system of claim 2, wherein the implantable medical device comprises: a haptic arm coupled to the intraocular lens at a flexible joint; a first coupling feature disposed on the implantable medical device proximate to the flexible joint; and a second coupling feature disposed on the drug delivery module configured to mate with the first coupling feature, wherein coupling of the drug delivery module to the implantable medical device is established and maintained by an interaction between the first coupling feature and the second coupling feature.

11. The drug delivery system of claim 2, wherein the drug delivery module comprises a rotation lock.

12. The drug delivery system of claim 1, wherein the coupling of the drug delivery module to the implantable medical device is reversible.

13. The drug delivery system of claim 1, wherein the coupling of the drug delivery module to the implantable medical device is irreversible.

14. A drug delivery system comprising: an implantable medical device selected to deliver a first treatment for a first condition of an individual patient; a drug delivery module having at least one sidewall defining a product well; and a module insertion assembly having a top body bearing a first alignment feature, a middle body with a module recess configured to receive the drug delivery module and bearing a second alignment feature, and a base body with an implant recess configured to receive the implantable medical device and bearing a third alignment feature, wherein the middle body is configured to reversibly couple between the base body and the top body by a coaxial interaction between the first alignment feature, the second alignment feature, and the third alignment feature, and wherein compressing the middle body loaded with a drug delivery module in the module recess between the base body loaded with the implantable medical device loaded in the implant recess and the top body by a force applied to the top body under a condition wherein the first alignment feature, the second alignment feature, and the third alignment feature are coaxial causes the drug delivery module to couple to the implantable medical device.

15. The drug delivery system of claim 14, wherein the implantable medical device is an intraocular implant.

16. The drug delivery system claim 14 wherein the module insertion assembly is disposable.

17. A kit comprising; an implantable medical device; and a module insertion assembly configured to receive the implantable medical device, wherein the module insertion assembly comprises a top body, a middle body, and a base body, and wherein the module insertion assembly is configured to couple a drug delivery module to the implantable medical device.

18. The kit of claim 17, wherein the implantable medical device is an intraocular medical device.

19. The kit of claim 18, wherein the intraocular medical device comprises an intraocular lens.

20. The kit of claim 17, wherein the module insertion assembly is disposable.